What is rotavirus oral vaccine (Rotarix)?

Rotavirus oral vaccine contains up to five strains of rotavirus. It is made from both human and animal sources.

Infection with rotavirus can affect the digestive system of babies and young children, causing severe stomach or intestinal illness.

The rotavirus oral vaccine is used to help prevent this disease in children.

This vaccine works by exposing your child to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Rotavirus oral vaccine is for use in children between the ages of 6 weeks and 32 weeks old.

Like any vaccine, the rotavirus oral vaccine may not provide protection from disease in every person.

What are the possible side effects of rotavirus oral vaccine (Rotarix)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous dose caused any side effects. Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if the child has a serious side effect such as:

Other less serious side effects are more likely to occur, such as crying or mild irritability.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What is the most important information I should know about rotavirus oral vaccine (Rotarix)?

Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to a rotavirus oral vaccine, or if the child has severe combined immunodeficiency disease (SCID). This vaccine should not be given if the child has a history of an intestinal problem called intussusception (in-tuh-suh-SEP-shun).

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Before your child receives this vaccine, tell the doctor if your child has recently had a fever. Also tell the doctor if anyone living with or caring for the child has cancer or a weak immune system, or is receiving treatments that can weaken the immune system (such as radiation, chemotherapy, or steroids).

Always wash your hands after handling the diapers of a child who has been given the rotavirus oral vaccine. Small amounts of the virus may be passed in the child's stool and could possibly infect others who come into contact with the child's stool.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous dose caused any side effects.

Be sure your child receives all recommended doses of this vaccine. Your child may not be protected from rotavirus if the doses aren't given within 4 to 10 weeks of each other, or if the child does not receive the full series of vaccines.

Avoid receiving the doses of this vaccine in different clinics or from different doctors. Your child should receive the same brand of rotavirus oral vaccine for all doses given. Different brands of this vaccine may not have the same dosing or booster schedule.

Call your doctor as soon as possible if your child (after receiving a rotavirus oral vaccine) has stomach pain or bloating, vomiting (especially if it is golden-brown to green in color), bloody stools, grunting or excessive crying, and eventually weakness and shallow breathing.

Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my health care provider before receiving rotavirus oral vaccine (Rotarix)?

Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to a rotavirus oral vaccine, or if the child has severe combined immunodeficiency disease (SCID).

If your child has any of these other conditions, this vaccine may need to be postponed or not given at all:

HIV or AIDS;

a current stomach illness or diarrhea;

a congenital stomach disorder or recent stomach surgery;

leukemia or other blood disease;

if the child is allergic to latex rubber; or

if the child has recently received a blood transfusion.

Rotavirus oral vaccine may cause intussusception in some people. Intussusception is when a section of the intestine folds over into itself, creating an obstruction in the bowel. Call your doctor as soon as possible if your child has stomach pain or bloating, vomiting (especially if it is golden-brown to green in color), bloody stools, grunting or excessive crying, and eventually weakness and shallow breathing.

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Tell the doctor if anyone living with or caring for the child has cancer or a weak immune system, or is receiving treatments that can weaken the immune system (such as radiation, chemotherapy, or steroids).

How is rotavirus oral vaccine given (Rotarix)?

Your child will receive this vaccine in a clinic, hospital, or doctor's office. The rotavirus oral vaccine is given as an oral (by mouth) liquid.

The RotaTeq brand of rotavirus oral vaccine is given in a series of 3 doses. The first dose is usually given when the child is 6 to 12 weeks old. The booster doses are then given at 4-week to 10-week intervals before the child reaches 32 weeks of age.

The Rotarix brand of rotavirus oral vaccine is given in a series of 2 doses. The first dose is usually given when the child is 6 weeks old. The second dose is then given at least 4 weeks after the first dose, but before the child reaches 24 weeks of age.

Your child's booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Tell your doctor if your child spits up or vomits within 1 or 2 hours after receiving rotavirus oral vaccine. The child may need to receive a replacement dose to be fully protected from rotavirus.

Always wash your hands after handling the diapers of a child who has been given the rotavirus oral vaccine. Small amounts of the virus may be passed in the child's stool and could possibly infect others who come into contact with the child's stool.

What happens if I miss a dose (Rotarix)?

Contact your doctor if you miss a booster dose or if you get behind schedule. Your child may not be protected from rotavirus if the doses aren't given within 10 weeks of each other. Be sure your child receives all recommended doses of this vaccine.

What happens if I overdose (Rotarix)?

An overdose of this vaccine is unlikely to occur.

What should I avoid after receiving rotavirus oral vaccine (Rotarix)?

Avoid receiving the doses of this vaccine in different clinics or from different doctors. Your child should receive the same brand of rotavirus oral vaccine for all doses given. Different brands of this vaccine may not have the same dosing or booster schedule.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect rotavirus oral vaccine (Rotarix)?

Before receiving this vaccine, tell the doctor about all other vaccines your child has received.

Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:

an oral, nasal, inhaled, or injectable steroid medicine;

chemotherapy or radiation;

medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

If your child is using any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete and other drugs may interact with this vaccine. Tell your doctor about all medications your child receives. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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